As regulators focus in on the critical quality attributes (CQAs) of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations assays – other than to run additional orthogonal assays?

Many labs are finding the answer in mass detection, specifically with the ACQUITY QDa Detector from Waters. Here are three ways that mass detection is being adopted for monitoring large molecules.

For companies developing biologics, a trend is for MS methods to be employed by labs further downstream in late stage development and manufacturing/QC to monitor CQAs and ensure control over product and processes. However, this can bring delays when samples need to be sent to a separate core MS lab for analysis. The ACQUITY QDa mass detector, which can be used by chromatographers with their existing bioseparations systems, allows these labs to collect their own mass data in a compliant manner, leading to streamlined workflows and faster time-to-results.

Mass data can be used to confirm the identity of each individual peptide peak in a peptide map, even if peaks may be partially or completely overlapping, and it can also be used to monitor the relative abundance of key peptide modifications (e.g., oxidized versus non-oxidized forms). Mass detection can also be used to confirm the identity of monoclonal antibodies (mAbs) by confirming via mass the signature peptides that make up the complimentary domain region (CDR) of the antibody.

For peptide analysis for biologics or synthetic peptide manufacturing, the addition of the ACQUITY QDa Detector can not only increase certainty of results via multiple attribute monitoring (MAM), but it can also improve process understanding and lead to greater productivity overall through streamlined workflows.

2. Increased Confidence in Monitoring Glycan Profiles

Attached glycans represent critical quality parameters of many biomolecules, and often they are monitored by LC-HILIC separations followed by optical/fluorescent detection. In general, biologic developers seek to develop a clear understanding of what glycan structures are on a molecule, and to monitor those structures throughout development and production to ensure the “glycoprofile” remains consistent.

Here, as with peptide analysis, the addition of the ACQUITY QDa mass detector can provide orthogonal mass confirmation of glycan peaks, greater sensitivity and selectivity relative to optical-only workflows, and the ability to identify partially or even completely overlapping peaks.

Mass detection is now possible for released N-glycans thanks to GlycoWorks RapiFluor-MS, a novel labeling technique from Waters that reduces the sample preparation process to just 30 minutes, while labeling the glycan with an MS-friendly tag that dramatically increases both FLR and mass response.

3. No loss in productivity for chromatographers

The ACQUITY QDa Mass Detector is designed for analytical chemists and chromatographers who have little to no mass spec experience. It’s as easy as adding an optical detector to an existing Empower Software workflow, requires no analyte-specific tuning, and automatically performs self-calibration checks on start-up to ensure consistent performance over time. A new mass analysis window allows for easy data visualization, and information is captured and managed within Empower 3 Software, already known for its GMP-compliant reporting.

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